Medical and Surgical Hybrid Treatment of Atrial Fibrillation. (HT2AF)

December 2, 2025 updated by: University Hospital, Toulouse

Medical and Surgical Hybrid Treatment of Atrial Fibrillation: Epicardial and Endocardial Combined Approach.

The objective of the study is to investigate the feasibility of a hybrid procedure removal of the atrial fibrillation.

This is a single procedure for both surgical epicardial by minimally invasive route (Thoracoscopy) without even flow controlled and supplemented if necessary by extra corporeal intracavitary route at the same time.

This faster procedure combined with complete lesions have a higher success rate and less frequent re-hospitalizations of patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi Pyrenees
      • Toulouse, Midi Pyrenees, France, 31059
        • University Hospital Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

patients with complex AF defined by the following criteria :

  • AF> 1 week or long term persistent> 1 year
  • AND Symptomatic
  • AND after failure of treatment of anti-arrhythmic or against-indication for anti-arrhythmic

Exclusion Criteria:

The exclusion criteria are relevant contraindications thoracoscopy or the non-complex nature of the AF:

  • Paroxysmal AF or AF cardioverted anti-arrhythmic test (unless against indicated)
  • Recent AF for which a simple gesture is intracavitary considered sufficient
  • Permanent AF
  • Asymptomatic AF
  • Very old AF (> 5 years) or atrial major ectasia (> 60 mm)
  • Need another surgery (valve bypass coronary)
  • Previous history of sternotomy or thoracotomy
  • High-risk surgical or anesthetic Patient
  • BMI> 35
  • Sleep Apnea
  • Ejection fraction <35%
  • Thoracic trauma history
  • Veins Pulmonary stenosis> 50%
  • Hyperthyroidism
  • Thrombus in LAA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
All patients will have the hybrid procedure of ablation of atrial fibrillation.
Device: The AtriCure Synergy Ablation System
The AtriCure Synergy Ablation System will be used on all patients for AF ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete procedure or not
Time Frame: 3 hours
At the end of the intervention, the doctor evaluates whether the procedure was complete with electric exclusion of the posterior wall of the left atrium and the 4 pulmonary veins.
3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of atrial fibrillation episode
Time Frame: 12 months
12 months
Stroke Rate
Time Frame: 12 months
12 months
Hospitalization for heart failure
Time Frame: 12 months
The number of hospitalizations for heart failure after hybrid procedure
12 months
Evaluation of Quality of life (EQ-5D according to the survey-3L)
Time Frame: 12 months
The quality of life will be measured using the EQ-5D 3L questionnaire (EQ-5D according to the survey-3L)
12 months
The cost-effectiveness ration
Time Frame: 12 months

Cost estimates will be conducted from the perspective of health insurance. The expenses incurred in the care of patients will be counted during the follow-up year.

The effectiveness will be assessed against the complications of strategy
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Bertrand Marcheix, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 11, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimated)

December 15, 2015

Study Record Updates

Last Update Posted (Estimated)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/14/7424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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